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Phoenix winnonlin version 7

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Phoenix WinNonlin version 7.0 is a software package for the analysis of pharmacokinetic and pharmacodynamic data. It provides tools for data visualization, model fitting, and statistical analysis.

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Lab products found in correlation

Sas version 9, by SAS Institute (2 mentions) Acetonitrile, by Merck Group (1 mentions) Nunc vials, by Thermo Fisher Scientific (1 mentions)

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Phoenix WinNonlin software Version 7.0 Phoenix WinNonlin 7.0 Phoenix® WinNonlin® version WinNonlin Version 7.0 Phoenix version 7.0 Phoenix WinNonlin WinNonlin 7.0 Phoenix® 7.0 WinNonlin

8 protocols using phoenix winnonlin version 7

1

Quantification of 6-Mercaptopurine in Rat Plasma

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The SD rats were orally administered 6-MPCs or 6-MPNs at a dose of 15.75 mg/kg. At various time points after administration, blood samples were collected from the orbit of the rats and centrifuged at 5000 g for 10 min at 4°C. The plasma samples were added with methanol to precipitate protein and then centrifuged at 16,000 g for 10 min.18 (link) The concentration of 6-MP in the supernatants was determined by HPLC-MS/MS.
MS analysis was performed using an API 5500 triple-quadrupole mass spectrometer (Applied Biosystems-Sciex, Toronto, Canada). The mobile phase consisted of methanol containing 0.5% v/v formic acid and water. Chromatographic separation was achieved with gradient elution on an Atlantis T3 column (2.1 mm × 100 mm, 5 µm) with gradient elution. We employed that a flow rate was 0.4 mL/min, a sample injection volume was 3 µL and a run time was 5 min. The column oven and autosampler were set at 37°C and 10°C, respectively. Multiple reaction monitoring transition was performed for quantitation at m/z 153.0 > 118.9 for 6-MP.19 (link) The pharmacokinetic parameters were calculated by the standard noncompartmental analysis (NCA) in Phoenix WinNonlin version 7.0 (Certara, Princeton, NJ).
Zou Y., Gao W., Jin H., Mao C., Zhang Y., Wang X., Mei D, & Zhao L. (2023). Cellular Uptake and Transport Mechanism of 6-Mercaptopurine Nanomedicines for Enhanced Oral Bioavailability. International Journal of Nanomedicine, 18, 79-94.
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2

Nivolumab Pharmacokinetics and Safety Study

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The sample size was based on the number of patients that was feasible to evaluate the safety and the pharmacokinetic profile of nivolumab and not on any statistical hypothesis. A minimum of five patients was enrolled in each treatment group, although up to 10 patients per group were allowed depending on their evaluability. The full analysis set (FAS) included all patients who were eligible for inclusion in the study and were administered nivolumab.
Summary statistics were used to calculate nivolumab pharmacokinetic and pharmacodynamic parameters. AEs were graded by CTCAE and were listed and tabulated by system organ class and preferred term for each treatment group (40 ).
Statistical analyses were performed using Phoenix WinNonlin Version 7.0 (Certara USA, Inc, Princeton, NJ), Autopilot Toolkit 7.0 (Certara USA, Inc, Princeton, NJ) and SAS Version 9.3 (SAS Institute, Cary, NC) for pharmacokinetic evaluation, and SAS Version 9.3 for all other analyses.
Watanabe E., Nishida O., Kakihana Y., Odani M., Okamura T., Harada T, & Oda S. (2019). Pharmacokinetics, Pharmacodynamics, and Safety of Nivolumab in Patients With Sepsis-Induced Immunosuppression: A Multicenter, Open-Label Phase 1/2 Study. Shock (Augusta, Ga.), 53(6), 686-694.
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3

Statistical Analysis of Pharmacokinetic Parameters

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Statistical analysis was conducted using SAS statistical software for Windows, Release V.9.4 (Armonk, NY, USA). Phoenix WinNonlin version 7.0 (Certara, Princeton, NJ, USA) was used for statistical analysis of the pharmacokinetic parameters. Descriptive statistics were presented using the mean and standard deviation, median, and interquartile range. An Analysis of Covariance (ANCOVA) model was used to calculate the least square mean (LSmean), the LSmean difference and the 95% confidence interval (95% CI) of efficacy outcomes between groups and time points with Tukey’s multiplicity correction. A Model check was performed to assess on statistically significant indicators, and the Kruskal–Walis test was used for indicators that did not meet the assumptions of normality and homogeneity of variance to further confirm the statistical differences. The Wilson score method was used to calculate 95% CI and the Newcombe–Wilson Score method was used for calculating confidence intervals of the difference in the proportion of patients achieving ≥ 30% reduction in liver biochemical parameters and LFC from baseline between two groups. All the statistical tests were two-sided, and a 5% type I error was used to reject null hypotheses.
Hu Y., Li H., Zhang H., Chen X., Chen J., Xu Z., You H., Dong R., Peng Y., Li J., Li X., Wu D., Zhang L., Cao D., Jin H., Qiu D., Yang A., Lou J., Zhu X., Niu J, & Ding Y. (2023). ZSP1601, a novel pan-phosphodiesterase inhibitor for the treatment of NAFLD, A randomized, placebo-controlled phase Ib/IIa trial. Nature Communications, 14, 6409.
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4

Pharmacokinetics of Regorafenib in Patients

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Patients were admitted to the hospital on the 21st, the 49th, and the 77th day of the trial for pharmacokinetic blood sampling. Blood samples were collected before regorafenib administration and at the 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, and 24‐hour timepoints after regorafenib administration (at 10:00 am). Blood samples were collected in 4‐mL lithium heparin blood collection tubes, processed into plasma within 10 minutes by centrifugation for 10 minutes at 2,500 g (at 4°C), and stored at T<−70°C until analysis. Regorafenib, M‐2, and M‐5 plasma concentrations were measured using a validated ultraperformance liquid chromatography–tandem mass spectrometry method (detailed description in Methods S1). Pharmacokinetic parameters were calculated by using Phoenix WinNonlin version 7.0 (Certara, Princeton, NJ), and included exposure expressed as dose corrected AUC0–24h, maximum observed concentration (Cmax), and time until maximum observed concentration (Tmax).
de Man F.M., Hussaarts K.G., de With M., Oomen‐de Hoop E., de Bruijn P., van Halteren H.K., van der Burg‐de Graauw N.C., Eskens F.A., van Gelder T., van Leeuwen R.W, & Mathijssen R.H. (2019). Influence of the Proton Pump Inhibitor Esomeprazole on the Bioavailability of Regorafenib: A Randomized Crossover Pharmacokinetic Study. Clinical Pharmacology and Therapeutics, 105(6), 1456-1461.
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5

Diurnal Pharmacokinetics of Compound PDDC

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12 mice (6 male/6 female) were enrolled in a PK study with n = 3/time point and the brain and plasma drug levels were quantified at 4 timepoints throughout the 24h day (00:00, 07:00, 12:00, and 19:00). Times were chosen based on the 14h light-10h dark cycle where 7:00 is when the lights come on and 19:00 was 2h before lights went off. Plasma was isolated from fresh whole blood by centrifugation at 500×g for 15min and stored at − 80°C until LC/MS/MS bioanalysis. Whole brains were harvested following blood collection and cut into hemispheres before freezing in liquid nitrogen and stored at − 80°C.
The bioanalysis was carried out as previously described(18 (link), 33 ). Briefly, protein precipitation using acetonitrile (Sigma-Aldrich, St. Louis, MO)(100% v/v) containing the internal standard (losartan 500nM; Tocris, Minneapolis, MN) was used to extract PDDC standards and samples from plasma and brain prior to vortexing and centrifugation at 10,000×g. The supernatant was diluted 1:1 with water and then analyzed via LC/MS/MS. Plasma (nmol/ml) and tissue (nmol/g) concentrations were determined and plots of mean plasma concentration versus time were constructed. Phoenix WinNonlin version 7.0 (Certara USA, Inc., Princeton, NJ) was used to quantify exposures (AUC0–t) using non-compartmental analysis modules.
Tallon C., Bell B.J., Malvankar M.M., Deme P., Nogueras-Ortiz C., Eren E., Thomas A.G., Hollinger K.R., Pal A., Mustapic M., Huang M., Coleman K., Joe T.R., Rais R., Haughey N.J., Kapogiannis D, & Slusher B.S. (2023). Inhibiting tau-induced elevated nSMase2 activity and ceramides is therapeutic in murine Alzheimer’s disease. Research Square.
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6

TriTAC Pharmacokinetics in Cynomolgus Monkeys

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Cynomolgus monkey studies were performed at Charles River Laboratories (Reno). TriTACs were administered intravenously by single slow bolus. Serum samples were stored frozen at À80 C until serum TriTAC levels were measured using an electrochemiluminescent ELISA assay. Pharmacokinetic analyses were performed using Phoenix WinNonlin Version 7.0 software (Certara).
Austin R.J., Lemon B.D., Aaron W.H., Barath M., Culp P.A., DuBridge R.B., Evnin L.B., Jones A., Panchal A., Patnaik P., Ramakrishnan V., Rocha S.S., Seto P., Sexton K., Strobel K.L., Wall R., Yu S., Yu T.Z., Law C.L., Baeuerle P.A, & Wesche H. (2021). TriTACs, a Novel Class of T-Cell-Engaging Protein Constructs Designed for the Treatment of Solid Tumors. Molecular cancer therapeutics, 20(1).
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7

Pharmacokinetics of Sublingual Fentanyl

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Pharmacokinetic (PK) samples were taken pre-dosing, and at 10, 20, 30, 40, 50, 60, 90, 180, and 360 min after administration of sublingual fentanyl.
Blood samples (4.5 mL) were collected in potassium ethylenediaminetetraacetic acid (EDTA) coated tubes and centrifuged for 10 min at 2500 to 3000× g at 4 °C. Plasma was transferred into polypropylene tubes (1.8 mL Nunc vials), which was stored at T < −70 °C (T < −20 °C during collection period) until the time of analysis. Fentanyl in plasma was quantitated using a validated UPLC-MS/MS method [33 (link)].
Pharmacokinetic data were analyzed by using Phoenix WinNonlin version 7.0 (Certara, Princeton, NJ, USA) to analyze concentration-versus-time data. Peak concentration (Cmax), time to peak concentration (Tmax), and area under the concentration-time curve (AUC) from 0 to 6 h after administration, were calculated.
Kuip E.J., Oldenmenger W.H., Oomen-de Hoop E., Verduijn G.M., Thijs-Visser M.F., de Bruijn P., van Meerten E., Koolen S.L., Mathijssen R.H, & van der Rijt C.C. (2018). Pharmacokinetics of Sublingually Delivered Fentanyl in Head and Neck Cancer Patients Treated with Curatively Aimed Chemo or Bioradiotherapy. Cancers, 10(11), 445.
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8

Pharmacokinetic Analysis of Dinaciclib and MK-2206

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Dinaciclib and MK‐2206 PK analyses were performed in patients enrolled in the dose escalation cohort at dose levels 2.5 and 3 and in all patients enrolled to the dose expansion cohort. For patients in the escalation cohort, a full dinaciclib PK profile was obtained from immediately prior to the end of infusion on cycle 1 day 1 through 8 hours. A full MK‐2206 PK profile was obtained from first dose on cycle 1 day 1 through 96 hours, and trough levels were collected on cycle 1 day 8 and cycle 1 day 15. For the expansion cohort, PK was collected when both drugs were administered alone (cycle 1) or in combination (cycle 2) with the same time points being collected. However, in arm A, only dinaciclib samples were collected during cycle 1, and, in arm B, only MK‐2206 samples were collected during cycle 1.
Plasma levels of total dinaciclib and MK‐2206 were determined using validated liquid‐chromatography tandem mass spectrometry methods (Supplementary Methods).
Dinaciclib and MK‐2206 concentrations were analyzed using Phoenix WinNonlin version 7.0 (Certara LP, Princeton, NJ) and by using standard noncompartmental PK methods.25 See Supplementary Methods for further details.
Murphy A.G., Zahurak M., Shah M., Weekes C.D., Hansen A., Siu L.L., Spreafico A., LoConte N., Anders N.M., Miles T., Rudek M.A., Doyle L.A., Nelkin B., Maitra A, & Azad N.S. (2020). A Phase I Study of Dinaciclib in Combination With MK‐2206 in Patients With Advanced Pancreatic Cancer. Clinical and Translational Science, 13(6), 1178-1188.
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